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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

DIPHENHYDRAMINE\IBUPROFEN: 3,969 Adverse Event Reports & Safety Profile

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3,969
Total FAERS Reports
111 (2.8%)
Deaths Reported
118
Hospitalizations
3,969
As Primary/Secondary Suspect
6
Life-Threatening
7
Disabilities

Active Ingredient: DIPHENHYDRAMINE CITRATE\IBUPROFEN ·

First Report: 2002 · Latest Report: 20250911

What Are the Most Common DIPHENHYDRAMINE\IBUPROFEN Side Effects?

#1 Most Reported
Product use in unapproved indication
970 reports (24.4%)
#2 Most Reported
Drug effective for unapproved indication
864 reports (21.8%)
#3 Most Reported
Drug ineffective
770 reports (19.4%)

All DIPHENHYDRAMINE\IBUPROFEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product use in unapproved indication 970 24.4% 0 2
Drug effective for unapproved indication 864 21.8% 0 0
Drug ineffective 770 19.4% 0 8
Somnolence 502 12.7% 1 5
Insomnia 146 3.7% 0 4
Intentional product misuse 142 3.6% 7 9
Feeling abnormal 138 3.5% 0 6
Incorrect dose administered 119 3.0% 1 1
Fatigue 108 2.7% 1 6
Dizziness 103 2.6% 0 10
Therapeutic product effect incomplete 87 2.2% 0 1
Off label use 86 2.2% 0 2
Drug effect incomplete 85 2.1% 0 1
Expired product administered 77 1.9% 0 1
Dysphagia 67 1.7% 0 7
Completed suicide 66 1.7% 66 14
Headache 65 1.6% 1 7
Therapeutic response unexpected 64 1.6% 0 0
Product use issue 63 1.6% 2 1
Wrong technique in product usage process 63 1.6% 0 0

Who Reports DIPHENHYDRAMINE\IBUPROFEN Side Effects? Age & Gender Data

Gender: 66.7% female, 33.3% male. Average age: 58.6 years. Most reports from: US. View detailed demographics →

Is DIPHENHYDRAMINE\IBUPROFEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 0
2010 3 0 1
2011 3 0 1
2012 3 0 0
2013 10 3 2
2014 82 2 4
2015 208 4 12
2016 175 10 10
2017 133 0 6
2018 120 4 6
2019 78 2 8
2020 46 3 4
2021 39 6 5
2022 36 0 1
2023 53 8 5
2024 23 0 0
2025 3 0 1

View full timeline →

What Is DIPHENHYDRAMINE\IBUPROFEN Used For?

IndicationReports
Insomnia 716
Pain 653
Sleep disorder 589
Product used for unknown indication 533
Headache 323
Migraine 290
Back pain 169
Arthralgia 83
Pain in extremity 63
Inflammation 56

DIPHENHYDRAMINE\IBUPROFEN vs Alternatives: Which Is Safer?

DIPHENHYDRAMINE\IBUPROFEN vs DIPHENHYDRAMINE\NAPROXEN DIPHENHYDRAMINE\IBUPROFEN vs DIPHENOXYLATE DIPHENHYDRAMINE\IBUPROFEN vs DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE DIPHENHYDRAMINE\IBUPROFEN vs DIPYRIDAMOLE DIPHENHYDRAMINE\IBUPROFEN vs DIPYRONE DIPHENHYDRAMINE\IBUPROFEN vs DIROXIMEL DIPHENHYDRAMINE\IBUPROFEN vs DISOPYRAMIDE DIPHENHYDRAMINE\IBUPROFEN vs DISTIGMINE DIPHENHYDRAMINE\IBUPROFEN vs DISULFIRAM DIPHENHYDRAMINE\IBUPROFEN vs DIVALPROEX

Official FDA Label for DIPHENHYDRAMINE\IBUPROFEN

Official prescribing information from the FDA-approved drug label.